On March 9, senior healthcare officials announced the release of two of the most extensive rulings ever passed around the way electronic health information (EHI) is exchanged:
Issued by the Centers for Medicare & Medicaid Services (CMS) and the HHS’ Office of the National Coordinator for Health Information Technology (ONC), the separate but interrelated rulings represent a huge step forward for interoperability and increased patient access, giving members unprecedented control over their health data.
Interoperability: When Two Systems Talk, Everyone Wins
In a world of rapidly evolving technologies, the seamless, secure exchange of data has become increasingly critical in all areas of our lives. The need for different systems to “talk” to each other in a common language is especially important in healthcare, where patients’ lives are at stake.
Since 2004, Congress has enacted several laws laying the groundwork to achieve the holy grail of interoperability; a national electronic health information exchange. In that time, the industry has been transitioning from paper records transmitted via fax to electronic health records (EHRs) which are being shared electronically more than ever before. Still, many barriers remain, with as many as one-third of hospitals reporting interoperability issues as recently as 2019.
With the finalized rulings, however, we now have a detailed blueprint for the seamless exchange of EHI—and it couldn’t have come at a more critical time. COVID-19 has made it clear just how important the ability to quickly and accurately collect and exchange health data can be.
Stakeholders across the spectrum will be affected by the rulings, including patients, providers, health plans, and healthcare IT vendors. While some of these players have already been preparing for these changes, others will be scrambling to meet the requirements and timing. In the sections below, we have highlighted the key changes each group can expect and the time frames in which they will take effect.
Patient Access & Provider Directory Application Programing Interfaces (APIs)
Effective January 1, 2021, CMS-regulated payers will be mandated to provide members with both a Patient API and Provider Directory API at no cost. This is the first time payers will need to comply with USCDI data set standards for exchanging EHI and FHIR API standards. This is also the first time health plans are being mandated to share claims and cost data with members.
- The Patient API: Allows members to access their healthcare data—both clinical and claims—using an app accessible via smartphone or other device of their choice.
- The Provider Directory API: Gives patients access to their health plan’s participating provider directory.
Both APIs promote patients’ ability to control their healthcare by allowing them to access their medical records on-demand, shop for care by comparing costs and quality, and understand treatment options. For providers, the introduction of new, standardized APIs injects competition into the market. No longer confined by the boundaries of their own EHRs, they will be able to choose “best of breed” IT tools that integrate into and complement existing IT solutions—without having to worry about the barriers of compatibility or overly burdensome costs.
Admission, Discharge, & Transfer Event Notifications
In the fall of 2020, hospitals, including psychiatric hospitals and critical access hospitals, will be required to send electronic notifications of a patient’s admission, discharge, and/or transfer to another facility. By prompting a patient’s care team or facility to reach out for follow-up care in a timely manner, these notifications will improve post-discharge transitions and overall patient care coordination. This is especially important in the case of value-based payment models, where participants may be at risk financially for costs resulting from poor care transitions.
- Payer to Payer Data Exchange
Effective January 1st, 2022, CMS-regulated payers will be required to implement a process to support payer-to-payer exchange of certain clinical data at the patient’s request, specifically the U.S. Core Data for Interoperability (USCDI). This will allow patients to take their data with them when they move plans, helping create a cumulative health record with their current and future payers. Beginning April 2022, state agencies will also be required to exchange Medicare and Medicaid dual enrollee data on a daily basis with CMS. Currently, only done on a monthly basis, the move to a daily exchange will improve benefit coordination for dually eligible individuals.
To help facilitate interoperability, the ONC Final Rule has established new regulations to prevent information blocking and anti-competitive behaviors by providers, developers of certified health IT products, health information exchanges (HIEs), health information networks (HINs), and payers. As defined by the 21st Century Cures Act, information blocking is the intentional withholding of electronic health information, no matter what system that information resides in.
The Ruling also specifies eight exceptions that do not constitute information blocking:
- Preventing Harm Exception
- Privacy Exception
- Security Exception
- Infeasibility Exception
- Health IT Performance Exception
- Content and Manner Exception
- Fees Exception
- Licensing Exception
While the rules will not be enforced for the first six months, those who engage in information blocking will be subject to penalties. These penalties can range from a monetary fine up to $1 million for IT developers, having the IT technology module be removed from being certified, or removal of a provider from a program.
- Implementation of Standards
For most certified healthcare IT vendors, there is already an infrastructure in place for standard data sets and API requirements (USDCI, FHIR), which will help reduce their development cost and burden. The new USCDI requirements include two new data sets, provenance and clinical notes, which vendors will also need to support within two years of the final ruling.
The USCDI standard initially being mandated is version 1. To expand the USCDI, the ONC will follow a predictable, transparent, and collaborative process, providing stakeholders the opportunity to comment on its expansion. To this end, the ONC will launch a website to solicit recommendation from the public for changes and additions to the USCDI and will be adding new data sets to each version based upon public feedback.
By adopting these interoperability standards, the ONC is setting the stage for a level playing field for nationwide data exchange. EHRs, health IT vendors, and health plans will all be speaking the same language when it comes to exchanging EHI data—and that is a win all around; most especially for patients and their care providers.
Stay tuned for further insights and analysis from Episource as we evaluate impacts of these regulations. For information on how the proposed rule differs from the final rule, read ONC’s description here and CMS’ notice here.